An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department

Completed

• Conditions: Pneumococcal Infections

• Registration Number: NCT01899365
• Lead Sponsor: Centre Hospitalier Princesse Grace

Brief Summary

Background :

Community-acquired pneumonia (CAP) is a threat in industrialized countries. It represents the 6th cause of death. CAP also frequently associates with other disorders responsible for admission and death. Among bacteria responsible for CAP, Streptococcus pneumonia is a major pathogen that is commonly involved and frequently leads to severe infection and admission. Categories at risk for this pathogen have been determined, and can be proposed anti-pneumococcal vaccination (APV) that efficiently and safely protects from this microorganism.

In the context of US health services, monocenter pilot experiences have reported improvement of pneumococcal prophylaxis implementing vaccination procedure at ED. A study that set in New Mexico (2003) reported a significant increase in APV (from 18% to 84%) when patients at risk were proposed vaccination at ED. To obtain these results, medical students were specifically trained and dedicated to screen and vaccinate against St. pneumoniae. Another single center trial (Tennessee, 2007) for APV at ED obtained an improvement (from 38.8 to 45.4%) when physicians were alerted for pneumococcal risk by the software they usually utilized at bedside. However these experiences remain sparse as additional dedicated resources are required or patients and attending ED physicians can be reluctant to proceed to vaccination at ED.

Mobile phone and derived communication modalities are current vectors to deliver information in several fields including education and medicine. Initially used in developing countries, short-message services (SMS) have improved behaviour of patients in various medical areas. In France, the investigators have observed that most patients above 50 years of age admitted after ED visit are equipped with mobile phone and can receive alerts by SMS.

These observations prompt us to propose a multifaceted procedure to improve APV after ED visit in at-risk patients, combining structured oral interview, written information and SMS as reminders.

Purpose : The investigators hypothesized that

* a multifaceted intervention to promote anti-pneumococcal vaccination combining a structured oral interview, a written information to patient and his/her general practitioner, and a series of 3 SMS,

* improves anti-pneumococcal vaccination at 6 months,

* in at-risk patients (65+ years) visiting the emergency department. In order to answer this question, the investigators designed an interventional prospective multicenter randomized study (cluster).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-04
• Study First Submitted QC: 2013-07-11
• Study First Posted: 2013-07-15
• Study Start: 2015-11
• Primary Completion: 2016-10
• Status Verified: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1475

Inclusion Criteria

• patients 65-year old and above,
• benefit from French or Monaco social security a social security.

Exclusion Criteria

• refuse to participate,
• no possibility to receive SMS,
• impaired cognitive functions and mental status precluding understanding of the study,
• anticipated barriers precluding adequate follow-up (ex. homeless),
• previous APV,
• contraindication to APV,
• do not understand/read French.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of a multifaceted procedure at ED visit on anti-pneumococcal vaccination. (APV) at 6-month. Evaluation criteria : Δ percentage (%) of APV vaccination at 6-month	6 month

Secondary Outcome Measures

Name	Time	Method
On death at 6- and 12-month (absolute number of events)	6 month
On death related to infection at 6- and 12-month (absolute number of events)	6 month
On Flu vaccination at 6-month Δ percentage (%)	6 month	number of patients receiving vaccination against flu at 6-month. This issue will be collected by phone (patient, relative or general practioner). This will be a declarative data
On episodes of respiratory tract infections requiring antibiotics or admission at 6-month Δ (absolute number of events)	6 month	number of patients who experienced respiratiory tract infection requiring antibiotics or admission. This issue will be collected by phone at 6-month (patient, relative or general practioner). This will be a declarative data
Psychosocial evaluation of patients and acceptance / refusal of vaccination	6 month	The patient will fil a Psychosocial evaluation questionnaire during the ED visit. To achieve this issue, we will use the socio-economic indicators mobilized in investigations in social epidemiology: sex, age, education, occupation, housing, income and household size. This composite questionnaire will be used for qualitative analysis.

Trial Locations

Locations (18)

Centre Hospitalier Universitaire de Clermont-Ferrand; 🇫🇷 Clermont-ferrand, France

Centre Hospitalier Paul Ardier; 🇫🇷 Issoire, France

AP-HM - Hôpital Nord; 🇫🇷 Marseille, France

HIA Laveran; 🇫🇷 Marseille, France

AP-HM - La Timone; 🇫🇷 Marseille, France

Centre Hospitalier La Palmosa; 🇫🇷 Menton, France

Centre Hospitalier Universitaire de Nice; 🇫🇷 Nice, France

Centre Hospitalier Louis Giorgi; 🇫🇷 Orange, France

Hôpital Lariboisière; 🇫🇷 Paris, France

Hôpital Cochin; 🇫🇷 Paris, France

Centre Hospitalier de Vaison-la-Romaine; 🇫🇷 Vaison-la-romaine, France

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France

Hôpital Bichat-Claude Bernard; 🇫🇷 Paris, France

Hôpital Tenon; 🇫🇷 Paris, France

Centre Hospitalier Jacques Lacarin; 🇫🇷 Vichy, France

Centre hospitalier de Saint-Denis; 🇫🇷 Saint-denis, France

Centre Hospitalier Jules Niel; 🇫🇷 Valreas, France

Centre Hospitalier Princesse Grace; 🇲🇨 Monaco, Monaco